Access to Medicines: Why Have Data Exclusivity as Well as Patents?
Teddy Henriksen1, University Of The Sunshine Coast Sippy Downs 1University Of The Sunshine Coast, Sippy Downs, Queensland, Australia
Abstract
Data exclusivity is a ‘right’ that gives originator pharmaceutical manufacturers sole use of the clinical trial data used in support of a marketing application. Once data exclusivity expires generic manufacturers can use abbreviated registration pathways to rely on the clinical trial data of the originator to support a generic marketing application. Therefore, while it is in force, data exclusivity prevents generic pharmaceutical manufacturers relying on originator clinical trial data. Generic pharmaceuticals bring down prices through competition in the market. Relying on the data provided by originators saves years in time and millions of dollars in generic development costs. Importantly, data exclusivity does not prevent generics performing their own supporting clinical trials. However, the cost impost of, and moral and ethical considerations around duplication of clinical trials provide a substantial barrier for generics. By contrast, prior to expiry, patents prevent generic competition absolutely. Both data exclusivity and pharmaceutical patents create monopolies that impede access to medicines by delaying generic competition. This paper explores whether pharmaceuticals need data exclusivity as well as patent protection. The traditional rhetoric is that without data exclusivity protection fewer new pharmaceuticals will enter the market. Similar arguments exist for the necessity of pharmaceutical patents with respect to developing new pharmaceuticals. Significantly, in pharmaceuticals, data exclusivity and patents are both potentially applicable to a single molecule, so these two regimes often coexist in relation to a new pharmaceutical.
Biography
Teddy is a Lecturer in Law at the University of the Sunshine Coast. Teddy holds bachelor degrees in law and pharmacy and a PhD in law. Teddy’s research interests revolve around access to medicines and how the law, including intellectual property law, affects people gaining timely, affordable access to medicines.